Headerbild Serum Life Science Europe GmbH

Company Overview

Serum Life Science Europe GmbH (SLS Europe) is a development consulting firm dedicated to the biopharmaceutical industry. Formerly known as Vakzine Projekt Management GmbH (VPM), we have successfully advanced and out-licensed cutting-edge biologics originating from academic research. Today, SLS Europe provides end-to-end consulting and services to guide novel medicinal products from the laboratory to global markets.

As part of the Serum Institute of India Pvt. Ltd. - the world’s largest vaccine manufacturer - we share in a global mission to deliver life-saving medications to people around the world. Our work contributes to a reality where two out of three children worldwide receive at least one vaccine from Serum Institute.

Position Overview

We are seeking a Regulatory Affairs Manager (m/f/d) to join our interdisciplinary team. In this role, you will manage and oversee the planning, preparation, and submission of regulatory documents to competent authorities worldwide. You will ensure that our projects and clients’ products comply with international regulatory standards, and that regulatory strategies are efficiently and effectively executed. Your expertise will support the development of innovative vaccines, biologics, and other medicinal products, making a tangible difference in global health.

Regulatory Affairs Manager (m/f/d)

Job Profile:

Develop and implement global regulatory strategies in support of product development, clinical trials, manufacturing, and market authorisations.
Coordination, submission, and management of national and international approval procedures (e.g., CTAs, INDs, MAAs) to European, U.S., and other international competent authorities.
Preparation, review and revision of documentation for regulatory applications (e.g. clinical, non-clinical, quality dossier/CMC, product information) in close collaboration with Subject Matter Experts.
Lifecycle and submission management of marketing authorisations.
Handling regulatory activities within the framework of change control procedures.
Serve as liaison with regulatory authorities, coordinating meetings, responding to inquiries, and managing timely follow-ups.
Collaborate closely with internal and external cross-functional stakeholders to align regulatory activities with product development milestones.
Monitor evolving regulatory requirements and ensure that internal processes and documentation remain compliant and up-to-date.
Document management and compilation of dossiers in eCTD format.

Requirements:

Advanced degree (Ph.D. preferred, or Master’s) in life sciences (e.g. biology, medicine, pharmacy).
Professional experience in regulatory requirements and legislation.
Several years of experience in the pharmaceutical industry.
Proven track record in preparing and managing regulatory submissions and successful interactions with regulatory authorities (EMA, FDA, etc.).
Deep understanding of global regulatory frameworks, guidelines (e.g. ICH, WHO), and GMP/GCP requirements.
Excellent English skills, both written and spoken.
Willingness to travel internationally (approximately 4 - 8 times per year).
Proficiency in common software packages (e.g. Microsoft Office), as well as familiarity with regulatory submission tools (e.g. eCTD software).
Self-organization, structured and precise working methods, and social competence.
Strong project management and communication skills, teamwork, flexibility, and a performance- and goal-oriented work approach.

What We Offer:

The opportunity to contribute to our mission of providing accessible, life-saving medications globally.
Hands-on involvement in innovative and challenging national and international regulatory projects for vaccines, biologics, and other advanced therapies.
A diverse, international team environment that fosters knowledge sharing, mutual support, and professional growth.
A comprehensive onboarding program, targeted training, and ongoing mentorship to ensure your success.
Professional development opportunities through internal and external training.
A competitive compensation package and benefits that reflect our commitment to sustainability and employee well-being.

Contact Details:

Serum Life Science Europe GmbH
Dr. Leander Grode, CEO
Ahrensburger Strasse 1
30659 Hannover
+49 (511) 1699080
email

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Vollzeit , Festanstellung

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Aktualisiert am 19.12.2024

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